Multi-Stage Nasal Filter and Method Of Tuning The Filter To A Predetermined Most Penetrating Particle Size
20210008397 ยท 2021-01-14
Inventors
Cpc classification
A61M11/02
HUMAN NECESSITIES
B01D2239/065
PERFORMING OPERATIONS; TRANSPORTING
B01D2239/0668
PERFORMING OPERATIONS; TRANSPORTING
B01D2239/0442
PERFORMING OPERATIONS; TRANSPORTING
A61M16/0087
HUMAN NECESSITIES
International classification
Abstract
Respiratory devices and methods for their manufacture and use are disclosed. The device features a resiliently deformable element configured to form a perimeter seal with the inner nostril wall and to swab the distal portion of the internal nostril region with a disinfectant during device installation. A first filter stage includes a first filter layer characterized by first geometric convolutions and a first MPPS1 value; and a second filter stage includes a second filter layer characterized by second geometric convolutions and a second MPPS2 value.
Claims
1. A method of installing a nasal filter device into a nostril, where the device includes a resiliently deformable component and first filter stage, the method comprising: manually opening a sealed envelope containing the device in a liquid antiseptic medium; removing the device from the package; inserting the device into a distal region of the nostril; and urging the device from the distal region upwardly into the nostril while simultaneously swabbing the distal region with liquid antiseptic medium present on the perimeter of the deformable component; wherein the first filter stage includes a first layer comprising three dimensional convolutions including a plurality of folded geometric features.
2. The method of claim 1 wherein the first filter layer is characterized by a most penetrating particle size (MPPS1) value in the range of 0.1 to 0.3 micrometers (um).
3. The method of claim 1 wherein the first filter layer is characterized by a most penetrating particle size (MPPS1) value of about 0.125 micrometers (um).
4. The method of claim 1 wherein the liquid medium comprises at least one of an antiseptic and a disinfectant, and wherein swabbing comprises rotating the deformable component against the distal region of the nostril while urging the device upwardly.
5. The method of claim 1 wherein the first filter layer comprises electrostatic material.
6. The method of claim 1 wherein the first filter layer comprises an electrospun material.
7. (canceled)
8. The method of claim 1 wherein: the nostril is characterized by a cross-sectional area of about K (inches).sup.2; and the convolutions are configured to impart an effective cross-sectional surface area to the first filter layer of at least 2k.
9. The method of claim 1 further comprising: leaving the device within the nostril for a period of time in the range of one to six hours; and thereafter removing the device from the nostril.
10. The method of claim 1 wherein the first filter layer is further characterized by two different values MPPS1 and MPPS1.2.
11. The method of claim 1 wherein the device further comprises a second filter stage having a second filter layer is characterized by a second MPPS2 value.
12. The method of claim 11 wherein the second filter layer comprises electrospun fibers having diameters in the submicron range.
13. A nasal filter device for inserting into a nostril having an internal nostril circumference, the device comprising: a first stage having a first filter layer; and a second stage having a second filter layer characterized by an MPPS2 value.
14. The device of claim 13 wherein the second filter layer comprises an electrospun material.
15. The device of claim 14 wherein the nostril is characterized by a cross-sectional area of about K (inches).sup.2; and the second filter layer comprises convolutions configured to impart an effective cross-sectional surface area to the second filter layer of at least 2K.
16. The device of claim 15 wherein the second stage comprises a resiliently deformable component configured to swab the distal region of the nostril interior with a disinfectant during device installation.
17. The device of claim 13 further comprising a third stage having a third filter layer characterized by an MPPS3 value.
18. The device of claim 17, wherein the third filter layer comprises an electrospun material, and wherein MPPS3 value is different from the MPPS 2 value.
19. The device of claim 17, wherein: the third filter layer comprises a flexible sheet loosely enveloping at least a portion of the second stage and forming an air gap therebetween; and the device includes a spring element configured to urge the distal portion of the second stage outwardly to form a perimeter seal with the inside of the nostril.
20. A nasal filter device comprising: a resiliently deformable element configured to form a perimeter seal with the inner nostril wall and to swab the distal portion of the internal nostril region with a disinfectant during device installation; a first filter stage having a first filter layer characterized by first geometric convolutions and a first MPPS1 value; and a second filter stage having a second filter layer characterized by second geometric convolutions and a second MPPS2 value.
Description
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0032] A more complete understanding of the embodiments of the present disclosure may be derived by referring to the detailed description and claims when considered in connection with the following illustrative figures, and:
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[0046] It will be appreciated that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to enhance clarity of the accompanying descriptions of various illustrated embodiments. Moreover, although various embodiments are illustrated in the context of a single device to be inserted into a single nostril, those skilled in the art will appreciate that each single filter assembly comprises one of a pair of identical or mirror image filters configured to be inserted into both nostrils.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0047] Various embodiments of the disclosure involve filter materials which may be characterized by either a pore size which generally corresponding to the smallest particle captured by the material, or a most penetrating particle size (MPPS) value which refers to a particle size at which the material is least efficient. That is, if a material demonstrates high performance (i.e., high filtering efficiency) at a particular MPPS value, then the material will collect particles both larger and smaller than the MPPS value at even higher performance. The present inventor has determined that both woven and non-woven material filter materials may be effectively tuned to one or more MPPS values by using small diameter fibers (e.g., submicron and nano-fibers) manufactured using techniques such as electrospinning, force spinning, and fiber splitting. (See, Synthesis and Applications of Electrospun Nanofibers by Ramazan Azmatula and Waseem Khan (ScienceDirect 2019); and Filter Media by Trevor Sparks and George Chase, Filters and Filtration Handbook (Sixth Edition) (2016).)
[0048] Sub-micron and nano-fibers may be used in the context of various embodiments to tune filter materials to one or more particular MPPS values, for example in the range of 0.001-100 microns, and alternatively in the range of 0.05-20 microns, such as 0.1-0.3 microns for typical influenza virus particle (including 0.125 microns for the Coronavirus). The MPPS values may also correspond to one or more specific particle sizes (=/0.1 to 10% of the nominal value) such as 0.1 micron, 0.15 microns, 0.2 microns, 0.25 microns, 0.3 microns, 0.35 microns, 0.4 microns, 0.5 microns, 1 micron, and fractional and/or integer multiples thereof.
[0049] In accordance with a further aspect of the invention, a particular filter layer may substantially or essentially comprise a single material or a plurality of materials. A particular filter layer may be manufactured or assembled using one or more processes including electrospinning, force spinning, and fiber splitting, in addition to or in lieu of woven and non-woven assembly techniques. A particular filter layer may comprise a substantially homogeneous distribution of fiber sizes of substantially the same length L and diameter D (where D may be on the order of 1 micron or greater, sub-micron, or in the range of nano-fibers).
[0050] In other embodiments, the layer may comprise a heterogeneous distribution of fiber materials and/or sizes expressed as, for example, the composition X %+Y % . . . +Z %; where X+Y . . . +Z=100, and X, Y, . . . and Z represent the relative amounts of the constituent components of the finished filter layer. For example, a layer may comprise 60% fibers of attribute X, 30% fibers of attribute Y, and 10% fibers of attribute Z; where X corresponds to a fiber diameter in the range 1 nanometer, Y corresponds to a fiber diameter in the range of 1 micrometer, and Z corresponds to a fiber diameter in the range of 1 micron. Alternatively, X, Y, and Z may represent a class or type of material such as a natural (e.g., cotton) or synthetic (e.g., a hydrocarbon chain) fiber.
[0051] As a further alternative, X, Y, . . . and Z may represent, in addition to or in lieu of the foregoing attributes, one or more material properties of a constituent component of the layer, including physical (e.g., tensile strength, shear strength), chemical (crosslinking or hydrogen bonding sites), and/or electromagnetic properties. In this regard, the present invention further contemplates that a particular filter layer may be cut from a larger sheet of material which itself comprises a single layer. Alternatively, the filter material may comprise one or more layers which may be adjacent and substantially parallel when in a planar orientation, or they may be interwoven, stitched, spot welded, thermally, chemically, and/or mechanically bonded, or otherwise interwoven to form an ordered or unordered matrix.
[0052] The various sublayers or subcomponents comprising the resulting filter material may be made from the same or different materials, made from the same or different manufacturing processes, and may comprises different thicknesses and other mechanical properties and may be loosely bound (or not bound at all) to all or a portion of one or more adjacent sublayers. In addition, each layer may be exhibit various degrees and/or combinations of surface features, nano and/or micro-geometric structures, electrostatic properties, surface finishes, surface properties such as tackiness and lubricity, and chemical and/or mechanical affinities to facilitate inter and intra layer bonding or adhesion.
[0053] In accordance with a further aspect of the invention, various combinations of the foregoing variables may be employed in an effort to best advance the foregoing design objectives. After measuring and recording the true MPPS values and other reliability and performance metrics, various input and control parameters may be iteratively adjusted in subsequent trials, for example employing machine learning techniques and related models to ultimately yield stable and cost effective protocols (or recipes) for producing filter materials which reliably and repeatedly exhibit the desired properties, including MPPS values.
[0054] Referring now to
[0055] The second stage filter may also include one or more sub-layers embedded into, circumscribing, or otherwise adjacent to the internal and/or external boundary surfaces of element 120. In addition, one or more of the filter layers may be convoluted; that is, the material may be folded, pleated, or otherwise configured to expand the effective surface area of the material in three dimensions as described in greater detail below in conjunction with
[0056] In this way the second stage may expand when inserted to form a gentle seal along a portion of its exterior perimeter with a corresponding region of the interior nasal walls. At the same time, the second stage filter material (and the other stages as well) may embody the desired MPPS value(s), without the high impedance associated with conventional planar filter layers typically implemented in two-dimensions.
[0057] With continued reference to
[0058] With continued reference to
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[0061] In an alternate embodiment, a fourth filter stage filter generally similar in size, shape, structure, and function to the third filter stage, may be disposed downstream (during inhalation) of the third stage filter and loosely encapsulating or circumscribing a portion of the third stage (to the right of element 333 in
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[0068] As shown in
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[0073] In various embodiments, pore sizes for the materials comprising the filter stages range from 0.001 microns to 1000 microns. Moreover, a particular filter stage may include multiple pore sizes (which may increase turbulence).
[0074] Additional embodiments may contemplate a filter wherein a particular stage itself comprises two stages, wherein the airflow is forced sideways along the inspiration path causing increased interaction with filter walls.
[0075] A further embodiment involves a single stage device for allergens, wherein the single stage comprises a compressible foam or other resiliently deformable material with entrained antiseptic.
[0076] A method is thus provided for installing a nasal filter device into a nostril, where the device includes a resiliently deformable component and first filter stage having a first filter layer. The method includes: manually opening a sealed envelope containing the device in a liquid antiseptic medium; removing the device from the package; inserting the device into a distal region of the nostril; and urging the device from the distal region upwardly into the nostril while simultaneously swabbing the distal region with liquid antiseptic medium present on the perimeter of the deformable component.
[0077] In an embodiment, the first filter layer is characterized by a most penetrating particle size (MPPS1) value in the range of 0.1 to 0.3 micrometers (um).
[0078] In an embodiment, the first filter layer is characterized by a most penetrating particle size (MPPS1) value of about 0.125 micrometers (um).
[0079] In an embodiment, the liquid medium comprises at least one of an antiseptic and a disinfectant, and wherein swabbing comprises rotating the deformable component against the distal region of the nostril while urging the device upwardly.
[0080] In an embodiment, the first filter layer comprises electrostatic material.
[0081] In an embodiment, the first filter layer comprises an electrospun material.
[0082] In an embodiment, the first filter layer comprises three dimensional convolutions.
[0083] In an embodiment, the nostril is characterized by a cross-sectional area of about K (inches)2; and the convolutions are configured to impart an effective cross-sectional surface area to the first filter layer of at least 2k, and in some cases 10k.
[0084] In an embodiment, the method further includes: leaving the device within the nostril for a period of time in the range of one to six hours; and thereafter removing the device from the nostril.
[0085] In an embodiment, the first filter layer is further characterized by two different values MPPS1 and MPPS1.2
[0086] In an embodiment, the device further comprises a second filter stage having a second filter layer is characterized by a second MPPS2 value.
[0087] In an embodiment, the second filter layer comprises electrospun fibers having diameters in the submicron range.
[0088] A nasal filter device is also provided for insertion into a nostril having an internal nostril circumference. The device includes: a first stage having a first filter layer; and a second stage having a second filter layer characterized by an MPPS2 value.
[0089] In an embodiment, the second filter layer comprises an electrospun material.
[0090] In an embodiment, the nostril is characterized by a cross-sectional area of about K (inches)2; and the second filter layer comprises convolutions configured to impart an effective cross-sectional surface area to the second filter layer of at least 2k, potentially 10k.
[0091] In an embodiment, the second stage comprises a resiliently deformable component configured to swab the distal region of the nostril interior with a disinfectant during device installation.
[0092] In an embodiment, the device further includes a third stage having a third filter layer characterized by an MPPS3 value.
[0093] In an embodiment, the third filter layer comprises an electrospun material, and wherein MPPS3 value is different from the MPPS 2 value.
[0094] In an embodiment, the third filter layer comprises a flexible sheet loosely enveloping at least a portion of the second stage and forming an air gap therebetween; and the device includes a spring element configured to urge the distal portion of the second stage outwardly to form a perimeter seal with the inside of the nostril.
[0095] A nasal filter device is also provided, comprising: a resiliently deformable element configured to form a perimeter seal with the inner nostril wall and to swab the distal portion of the internal nostril region with a disinfectant during device installation; a first filter stage having a first filter layer characterized by first geometric convolutions and a first MPPS1 value; and a second filter stage having a second filter layer characterized by second geometric convolutions and a second MPPS2 value
[0096] A method is also provided for impeding the inhalation of particulates using a resiliently deformable filter packaged in a sealed envelope containing a liquid medium. The method includes: opening the sealed package to thereby expose the filter to ambient air; removing the filter from the package; inserting the filter into a distal region of a nostril; and urging the filter from the distal region to a proximal region of the nostril while simultaneously swabbing the distal region with liquid medium present on the perimeter of the filter.
[0097] In an embodiment, the filter is characterized by a mean pore size in the range of 0.1 to 100 micrometers (um), and preferably 0.5 to 50 um, and most preferably 0.1 to 10 um.
[0098] In an embodiment, the particulates comprise allergens, and further wherein the filter is characterized by a mean pore size in the range of 3 to 7 um.
[0099] In an embodiment, the liquid medium comprises an antiseptic.
[0100] In an embodiment, the liquid medium comprises a disinfectant.
[0101] In an embodiment, the particulates comprise microorganisms.
[0102] In an embodiment, the particulates comprise allergens.
[0103] In an embodiment, the filter comprises electrostatic material.
[0104] In an embodiment, the liquid medium comprises povidone iodine.
[0105] In an embodiment, swabbing comprises rotating the filter within the distal region of the nostril.
[0106] In an embodiment, swabbing comprises simultaneously rotating and urging the filter upwardly within the nostril.
[0107] In an embodiment, the method further includes: leaving the filter within the proximal region for a period of time in the range of five minutes to eighteen hours; and thereafter removing the filter from the nostril.
[0108] In an embodiment, the method further includes: leaving the filter within the proximal region for a period of time in the range of one to six hours; and thereafter removing the filter from the nostril.
[0109] In an embodiment, the filter further comprises a pair of filters connected by a band.
[0110] In an embodiment, the method further includes removing the pair of filters from respective nostrils by manually pulling on the band.
[0111] In an embodiment, the filter further includes: an initial stage characterized by a first pore size; an intermediate stage characterized by a second pore size; and a final stage characterized by a third pore size; wherein the third pore size is a smaller than the first and second pore sizes.
[0112] A nasal filter is provided for insertion into a nostril having an internal nostril circumference. The filter includes: an initial stage characterized by a first pore size; an intermediate stage characterized by a second pore size; and a final stage characterized by a third pore size; wherein the third pore size is a smaller than the first and second pore sizes.
[0113] In an embodiment, the initial stage comprises a perimeter ring supporting a substantially planar filter material; the intermediate stage comprises a resiliently deformable filter material having a substantially flat distal end adjacent the initial stage and a dome shaped proximal end; and the final stage comprises a sheet of fabric loosely enveloping the intermediate stage and forming an air gap therebetween.
[0114] In an embodiment, at least one of the initial, intermediate, and final stages comprise an antiseptic coating.
[0115] In an embodiment, the resiliently deformable filter material is configured to urge the sheet of fabric against internal nostril circumference.
[0116] The description of exemplary embodiments of various filter stages and their materials and functions is merely exemplary and is intended for purposes of illustration only; the following description is not intended to limit the scope of the disclosure or the claims. Moreover, recitation of multiple embodiments having stated features, compositions, or properties is not intended to exclude other embodiments having additional features, compositions, or properties, or other embodiments incorporating different combinations of the stated features, compositions, or properties, unless otherwise noted herein.
[0117] Although exemplary embodiments of the present disclosure are set forth herein, it should be appreciated that the disclosure is not so limited. For example, although materials, media, apparatus, systems, and methods are described in connection with multi-stage filters, the invention may also be used in the context of single stage filters. Various modifications, variations, and enhancements of the materials, methods, and media set forth herein may be made without departing from the spirit and scope of this disclosure.